Medical Devices

Vascular Solutions Inc. Recalls Venture Catheters due to Excess Material that May Split or Separate During Use

The FDA has identified this as a Class I recall, the most serious type of recall. Use of these devices may cause serious injuries or death.

Recalled Product

  • Venture RX Catheter (Model 5820), Venture OTW (Model 5821), and Venture CS  Catheter (Model 5822)
  • Lot Numbers: See Full List Below
  • Distribution Dates: May 7, 2015 to April 19, 2017
  • Manufacturing Dates: May 7, 2015 to March 31, 2017
  • Devices Recalled in the U.S.: 7054 nationwide

Device Use

The Venture catheter is intended for directing, steering, controlling, and supporting a guidewire to access veins and arteries in the arms, legs, hands, feet, and heart muscle (myocardium). Certain models may also administer saline fluids or drugs into blood vessels.

Image of the device.

Reason for Recall

Vascular Solutions Inc. is recalling the Venture catheter because there is a risk of the catheter tip splitting or separating during use. Excess material at the tip of the catheter may separate and could enter the patient's bloodstream. This can result in serious adverse health consequences such as the development of blood clots, embolism of the excess material to vital organs, or death.

Who May be Affected

  • Health care providers using this device during vascular procedures
  • All patient groups undergoing procedures involving Venture catheters

What to Do

On April 25, 2017, Vascular Solutions Inc. sent an Urgent Medical Device Recall letter to all affected customers. The letter asked distributors and customers to:

  • Identify and remove any affected Venture catheters from inventory and quarantine.
  • Ensure all customers who received any affected Venture catheters receive the Field Safety Notice and complete the Customer Inventory Form.
  • After all the affected catheters are returned, complete the Vascular Solutions Inc. Distributor Inventory Form, and return it via email to regops@vasc.com.
  • Upon receipt of the Vascular Solutions Inc. Distributor Inventory Form, Vascular Solutions' Customer Service Department will provide a Return Authorization number and arrange for return of affected Venture catheters. A credit will be offered after affected devices have been returned.

Contact Information

Health care professionals and consumers may contact Vascular Solutions at 1-888-240-6001 Monday through Friday, between the hours of 8:00 a.m. and 5:00 p.m. Central Time or by email at customerservice@vasc.com with any questions related to this recall.

Date Recall Initiated

April 25, 2017  

How do I report a problem?

Health care professionals and consumers may report adverse reactions or quality problems they experienced using these devices to MedWatch: The FDA Safety Information and Adverse Event Reporting Program either online, by regular mail or by FAX to 1-800-FDA-0178.

Full list of Product Codes and Lot Numbers

Product CodeLot
5820582455
5820582588
5820583022
5820583409
5820584469
5820584470
5820585180
5820585458
5820585787
5820587035
5820587036
5820587775
5820588097
5820588098
5820588794
5820589885
5820589886
5820590172
5820590776
5820591196
5820591198
5820592080
5820592526
5820593080
5820593519
5820593720
5820594204
5820594421
5820595195
5820595418
5820597293
5820597771
5820597967
5820598903
5820599045
5820599466
5820599903
5820601745
5820603987
5820603988
5820603991
5820604500
5821581713
5821583410
5821584471
5821585459
5821586408
5821586972
5821587408
5821588099
5821589268
5821589754
5821590404
5821591197
5821592081
5821592924
5821593520
5821595196
5821595419
5821596020
5821597294
5821599650
5821601196
5821601746
5821602260
5821603990
5821604049
5821605617
5822588100
5822590562
5822597905
5822599777
5822604862

 

Page Last Updated: 10/10/2017
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